Senior Specialist Quality Control

Accountabilities:
Quality Control Maintenance Planning
- Retention of maintenance technical documents
- Retrieval, filing, and archiving of preventive maintenance and corrective maintenance work orders
- Review assigned SAP PM notifications and ensure complete and proper information is recorded
- Convert and release assigned work orders (Corrective Maintenance and Preventative Maintenance)
- Plan maintenance jobs for assigned areas ensuring coordination with area customers and area availability (includes Microbiology, Components, and Chemistry support)
- Determine if work order needs SHE or QA review and approval; execute the review process
- Create weekly work order schedule and participate in planning/scheduling meetings to monitor status, effectiveness of schedule, customer needs, and resource availability
- Monitor the area metrics and plan work according to equipment and process criticality
- Owner of metrics for QC Maintenance and Critical equipment issues
- Ensure consistent use of SAP as a Planning Scheduling tool and identify continuous improvement opportunities and business benefits for QC Maintenance activities and processes in support of Lean and Maintenance Reliability efforts
- Scope work orders and identify materials needed for work activities
- Purchase work order material, track committed deliveries, and kit and stage material for work execution
- Coordinate with Procurement and Storeroom personnel on material availability and expediting
- Coordinate contracts covering specific services as needed, including repairs/maintenance as well as miscellaneous site services
- Responsible for direct oversight of contracted work

Reliability Support
- Serve as the Subject Matter Expert for HPLC and Dissolution repair and maintenance
- Perform routine troubleshooting, maintenance, and repair for HPLC systems, Dissolution systems, and Dissolution autosamplers
- Create and manage PM plans and task lists for both GMP and non-GMP equipment
- Create and manage support document masters for all PM and calibration activities
- Maintain QC CMMS Master Data as needed
- Track and follow-up to ensure that PM and calibration activities are scheduled and completed according to schedule
- Review PM and calibrations ensuring that complete and proper information is populated
- May attend weekly planning/scheduling/resource meetings to provide scheduling knowledge and assistance with planning and scheduling efforts

Subject Matter Expert Role
- Site subject matter expert for the QC equipment PM and calibration process
- Provide equipment repair, PM maintenance, and Calibration documentation as required by Compliance, audits, and internal customers

Continuous Improvement Work
- Ensure consistent use of SAP and identify continuous improvement opportunities and business benefits for QC Maintenance activities and processes in support of Lean and Maintenance Reliability efforts
- Collaborate with site Maintenance Planning Analyst, Planners, and Facilitators to evaluate and audit process metrics to identify issues and improvement opportunities related to SAP
- Actively participate in changes to business processes, providing SAP support/coordination
- Actively work to improve upon and maintain SAP master data integrity as it applies to QC
- Provide support in updating SOPs as needed

Essential Skills/Experience:
- Bachelor’s degree in a science related field, preferably engineering or chemistry

- 3+ years of demonstrated relevant experience in Quality Control lab setting.

- Proficiency in Microsoft Word, Excel, and PowerPoint
- Working knowledge of GMPs as related to testing, release, and documentation in the pharmaceutical industry
- Self-motivated and capable of working with minimal supervision in a customer-focused team environment
- Strong interpersonal and communication skills
- High attention to detail needed to check complex work for accuracy and completeness
- Strong organization, administrative, and time-management skills
- Ability to make good business decisions using sound judgment

Desirable Skills/Experience:
- Pharmaceutical/cGMP maintenance training and experience
- 3+ years of demonstrated relevant experience in Quality Control lab setting
- Formal related SAP training

At AstraZeneca, we are driven by a passion for quality that permeates every aspect of our operations. Our commitment to innovation ensures that we are always at the cutting edge of technology, striving to improve reliability in our processes. We foster an inclusive environment where collaboration is key, empowering each team member to contribute their unique perspectives. With a focus on patient-centricity, we are dedicated to delivering